The invention relates in particular to a device, a system and a method for the processing and separation of biological fluids into components of the type known from EP-B-0 912 250 and EP-B-1 144 026. Such known devices comprise a hollow centrifugal processing chamber rotatable about an axis of rotation. The processing chamber usually has an inner cylindrical wall enclosing a space for receiving biological fluids to be processed and having an inclined upper wall leading to a neck with an inlet/outlet for biological fluid to be processed and for processed components of the fluid. The space in the hollow processing chamber for receiving biological fluids occupies the entire volume across the hollow processing chamber between facing parts of the inner cylindrical wall and along the length of the cylindrical wall, said space having a given volume delimited by a bottom of the hollow cylindrical chamber, or a variable volume delimited by the position of an axially movable member within the cylindrical wall. The device also comprises a dynamic/static inlet/outlet head or “rotary seal” mounted on the neck of the processing chamber. The inlet/outlet head has a first part rotatable with the processing chamber and a second part that remains stationary. The first and second parts of the inlet/outlet head have a sealing means allowing rotation of the first part relative to the second part. The inlet/outlet head has a central through-passage for the inlet of biological fluid to be processed and the outlet of processed/separated components of the fluid.
Typically the centrifugal processing chamber contains within its cylindrical wall an axially movable member such as a piston that defines a separation space of variable volume wherein the biological fluid to be processed and separated is received. By axially moving this member, biological fluids can be intaken or output.
This known device forms part of a system wherein the processing chamber is part of a disposable set comprising a plurality of containers for receiving on the one hand the biological fluid to be processed and separated and, on the other hand, the separated components, and optionally one or more additional containers for additive solutions.
The known device and system are suitable for processing and separating many types of biological fluids including whole blood, apheresis blood, bone marrow blood and expanded cells or stem cells. However, the quantity of biological fluid that can be processed/separated at one time is limited by the maximum volume of the processing chamber's separation space. Therefore, in order to process large volumes of biological fluids with this known device and system, it is necessary to resort to using multiple disposable sets one after another in a single apparatus, or to run several disposable sets in parallel in multiprocessing apparatus.
Other devices for processing and separating biological fluids are known, but their structure is incompatible with that of EP-B-1 144 026 and they do not achieve the same advantages as EP-B-1 144 026. For example WO 2012/137086 describes a blood centrifugal device with a rotatable inner bowl disposed within a rotatable housing defining therebetween a narrow gap for receiving the blood being processed. A stationary structure is disposed in a central recess along the central axis of the device for delivering blood from an inlet at the top to the bottom where it passes into the bottom end of the narrow gap. At the top of the gap a separator separates blood components.